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Adverse Drug Events Reporting Process

 

Introduction

SME: Director of Pharmacy
Last Review Date: 1/16/13

 

Definitions

 

Adverse Drug Event (ADE): An adverse drug event is “an injury resulting from the use of a drug. Under this definition, the term ADE includes harm caused by the drug (adverse drug reactions and overdoses) and harm from the use of the drug (including dose reductions and discontinuations of drug therapy).”   Adverse Drug Events may results from medication errors but most do not.

 

Adverse Drug Reaction (ADR): Any response to a drug that is harmful or unintended and that occurs at doses used in man for prophylaxis, diagnosis, or therapy, excluding failure to accomplish the intended purpose. This does not include side effects (expected, well known reactions resulting in little or no change in patient management) or any drug effects, which may occur when the drug is given inappropriately. Allergic and idiosyncratic reactions are also considered ADRs

 

Medication Error (ME):   Medication errors are mishaps that occur during prescribing, transcribing, dispensing, administering, adherence, or monitoring a drug. Examples of medication errors include misreading or miswriting a

prescription. Medication errors that are stopped before harm can occur are sometimes called “near misses” or  more formally, a potential adverse drug event. Not all prescribing errors lead to adverse outcomes. Some do not cause harm, while others are caught before harm can occur (“near-misses”).

 

Medication Use Process: The cycle of medication management that includes ordering, dispensing, administering, and monitoring. The cycle also includes all systems supporting these processes.

 

 

GENERAL PROCEDURE

 

All actual and potential adverse drug event occurrences shall be recorded on the UT-HCPC intranet webform by nursing or pharmacy staff or on the adverse drug reaction form by physicians utilizing the Sunrise clinical manager program. In the event of a computer failure, the hard copy ADE Reporting Form is available at each nursing unit when the computer system is down. This form must be completed with specific, factual, and objective information so that the true magnitude and nature of circumstances can be studied.

 

When the ADE intranet form is completed online, it will automatically be routed to the appropriate managers for acknowledgement. When the Adverse Drug Reaction form is complete in Sunrise, the patient chart will be flagged with information on the medication suspected causing the ADR.

 

Actual or suspected adverse drug reactions must also be documented in the progress notes of the patient’s chart.

 

As a private and confidential document, any printed version of the ADE Form must not be:

 

i. Left in a patient’s room or shared with personnel other than those specified by the procedure below

 

ii. Referenced or placed in a patient’s chart or an employee’s file

 

iii. Copied

 

 

A healthcare professional who witnesses or first discovers that an adverse drug event (ADE) has occurred shall record the information in accordance with the procedures section of this document. All recorded ADEs shall be reported to the Pharmacy and Therapeutics Committee,  the Safety Committee, and the Performance Improvement Committee. Intentional failure to report a known adverse drug event may be investigated and appropriate action taken.

 

 

REPORTING PROCEDURES FOR SPECIFIED INDIVIDUALS

 

 

Procedure for Healthcare Worker Nurse:

 

1. Identifies suspected adverse drug event

 

2. Documents pertinent diagnostic information on the medical record for adverse events resulting in temporary or permanent patient harm.

 

3. Contacts Physician immediately if patient care is affected.

 

4. Completes Adverse Drug Event Form located on the intranet under Webforms. In the event  the computer system is down the nurse will fill out the ADE form located on the nursing unit and forward to the Nursing Supervisor/Manager.

 

Procedure for Healthcare Supervisor:

 

1. Reviews and completes Adverse Drug Event Form via computer.

 

2. Provides follow-up and corrective actions

 

3. Forward completed ADE form to Pharmacy.

 

Procedure for Physician utilizing Sunrise to record ADRs:

 

1. Assesses patient for suspected adverse drug event resulting in temporary or permanent patient harm.

 

2. Determines and orders measures as appropriate to resolve the suspected adverse drug reaction:

 

a. Diagnostic testing

 

b. Monitoring of vital signs

 

c. Administration of medications, antidotes, intravenous fluid and supportive therapy

 

Procedure for Pharmacy Service:

 

1. Pharmacy Reviews adverse drug event form for completeness and investigates immediately.

 

2. Contacts Nurse Manager /Supervisor and Prescribing Physician, immediately if patient care is affected.

 

3. All ADE paper forms will be filed within the Pharmacy Department for record keeping.

 

4. ADEs with index level > 4 will be drilled down by all the disciplines involved (Pharmacy, Nursing and Medicine) with an action plan to prevent further ADE’s.

 

5. Pharmacy will trend and report findings for educational purposes to:

 

i. Pharmacy & Therapeutics (P&T) Committee

 

ii. The Safety Committee

 

iii. Performance Improvement Committee

 

iv. Medical Executive Committee

 

v. Nursing Director

 

 

6. Maintains record of reported adverse events for a period not less than 2-years from the date reported to the Pharmacy & Therapeutic Committee. 

 

7.  Pharmacy will report adverse drug reactions to the Food and Drug Administration when appropriate via the MedWatch reporting system.

 

IV. ADE/ADR INVESTIGATION AND ANALYSIS

 

a. All completed ADE forms will be entered into a database consistent with the ADE form.

 

b. All ADEs will be:

 

i. Verified for completeness and accuracy by Pharmacy

 

ii. Routed to related health care professional and administrators

 

iii. Investigated by the department involved

 

iv. Investigated for root cause (sentinel events)

 

c. The ADE database will minimally be trended by:

 

i. Cause or potential cause

 

ii. Drug

 

iii. Patient Outcome

 

iv. Units

 

v. Persons involved

 

vi. Benchmarks

 

vii. Variance

 

 

d.  A  quarterly report presenting trended and aggregated data will be presented to The Safety Committee for review.

 

e. The Plan-Do-Check-Act approach will be applied to improve identified deficient processes and outcomes through performance improvement projects.

 

f. Quarterly reports will be forwarded to Pharmacy and Therapeutics with recommendations for follow-up actions

 

g. Annual evaluation of the Medication Use Process will be performed based on the outcomes identified

 

 

 

 

 

 

 

 

ADE Variance Index and Patient Outcome

 

 

 

 

0

Potential Error

No actual occurrence

Level 1

Occurrence did not result in patient harm

Level 2

Occurrence resulted in the need for increased patient monitoring with no change in vital signs and no patient harm

Level 3

Occurrence resulted in the need for increased patient monitoring with a change in vital signs but no ultimate patient harm, or any occurrence that resulted in the need for increased laboratory monitoring

Level 4

 

Occurrence resulted in need for treatment with another drug or an increased length of stay

Level 5

Sentinel Event

Occurrence resulted in permanent patient harm

Level 6

Sentinel Event

Occurrence resulted in patient death

 

 

 

 

???

                                                                                                                                                                                                                                   

Definitions for Types of Errors or Occurrences:

 

Documented Allergy: Patient had a documented allergy to an administered medication or another medication in its class

 

Drug/Drug Interaction: Dispensing or administering a medication that has potential for drug /drug interaction

 

Drug/nutrient interaction: Drug administered with food or drink that alters its absorption or metabolism

 

Omission: Failure to administer an ordered dose; excludes patient’s refusal and a clinical decision or other valid reason for not administering

 

Therapeutic Duplication: The unintentional or unnecessary use of multiple agents from the same chemical family or therapeutic class.

 

Wrong Dose: A dose that is greater than or less than the amount ordered by the prescriber or duplicate doses

 

Wrong Medication: A medication other than one authorized by the prescriber was dispensed or administered to patient

 

Wrong Time: A scheduled dose administered outside HCPC acceptable predetermined time interval. A deferral in the administration of a prescribed medication; excludes patient’s refusal, a clinical decision to delay or other valid reason for not administering. This differs from omission in that a dose is not actually missed.

 

Wrong Frequency: A medication given at an interval different than prescribed or at a prescribed frequency outside of practice standards or guidelines

 

Wrong Patient: A medication prescribed for the wrong patient or given to a patient different than prescribed.

 

Incomplete medication order/prescription: An order or prescription that does not contain required components for processing (e.g. dose, route, dosing instructions, physician signature, etc.)

 

 

Definitions for Categories of Error:

Prescribing: The inappropriate selection of a drug (based on indication, contraindications, known allergies, existing drug therapy, and other factors); dose; dosage form; quantity; route of administration; concentration; rate of administration; or inappropriate or inadequate instructions for use of a medication ordered by a physician or other authorized prescriber.

Dispensing: The failure to dispense a medication upon physician order or within a specified period of time from receipt of the medication order or reorder ; dispensing the incorrect drug, dose, dosage form; failure to dispense correct amount of medication; inappropriate, incorrect, or inadequate labeling of medication; incorrect or inappropriate preparation, packaging, or storage of medication prior to dispensing; dispensing of expired, improperly stored, or physically or chemically compromised medications.

 

Administration: Failure to administer a drug in the prescribed manner or administration of a drug utilizing incorrect or inappropriate techniques.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

UT-HARRIS COUNTY PSYCHIATRIC CENTER

 

ADVERSE DRUG EVENT REPORT

 

DO NOT PLACE IN MEDICAL RECORD

 

 

 

 

(PATIENT STAMP)

 

Date of Report: ______________________  Reporting Individual (Circle one. Do not include names)

                                                                                    RN      RPh     MD      Other: ________________

 

Date / Time of Notification: ____________  Date / Time of Error: ____________________________

 

ADVERSE DRUG REACTIONS (PART I AND II)

 

INSTRUCTIONS: Any possible adverse drug reaction must be documented in the patient’s medical record. After completion of Part I and II of this form, forward to the Pharmacy. After review, Pharmacy submits the form to Data Management.

Suspected Drug(s):___________________________________________________________________

Dose of major drug suspected of causing adverse drug event:_________________  Route: __________

 

??????Type of report             ADR                           Med Error

 

PART I: To be completed by the Nurse, Physician or Pharmacist

 

  1. Date / Time signs and symptoms recognized: ______________________________________________
  2. Describe signs and symptoms of suspected drug reaction:____________________________________

__________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

__________________________________________________________________________________

  1. Severity (check one): __________Severe __________Moderate
  2. Was the drug discontinued? _________________ When? ____________________________________
  3. Name of MD notified ________________________________________________________________
  4. Treatment ordered for the reaction: _____________________________________________________
  5. Did the reaction subside after treatment (Yes, No, N/A)? ____________________________________
  6. Signature of person filing the report __Not Needed_____________________________________
  7. Name of Pharmacist notified: ____________________________ Date / Time: ___________________

 

PART II: Classification (Must choose one)

ADE Variance Level

Patient Outcome

Level 0

No actual occurrence

Level 1

ADR with no observable change in patient status and no extension of length of stay (LOS).

Level 2

ADR resulting in need for increased monitoring of patient condition. Drug was changed or held due to reaction, resulting in possible extension of LOS.

Level 3

ADR with resulting change in vital signs, additional labs, but no permanent harm

Level 4

ADR with resulting need for treatment with another drug, but no permanent harm

Level 5

ADR resulting in a permanent harm to the patient and a need to file a sentinel event report

Level 6

ADR resulting in death of the patient and a need to file a sentinel event report

 

MEDICATION ERRORS (PART III AND IV

 

PART III. Type of Event (Check all that apply)

Prescribing:

_____A. Inappropriate Medication           _____G. Wrong Duration                    ____M. Verbal Order Misunderstood

_____B. Wrong Medication                      _____H. Wrong Patient                      _____N. Verbal Order Not In Chart

_____C. Inappropriate Dose                      _____I.  Duplication                           _____O. Non-Formulary

_____D. Wrong Dose                                _____J. Order Not Dated / Timed       _____P. Order Not In MAR

_____E. Wrong Time                                _____K. Wrong Chart                         _____Q. Other (explain on back)

_____F. Wrong Frequency                        _____L. Contraindication (i.e. allergy)

Prescription / Dispensing:

_____A. Inaccurate Labeling                   _____D. Wrong Dose                          _____G. Wrong Frequency     

_____B. Wrong Quantity                         _____E.  Delay in Delivery                 _____H. Other (explain on back)

_____C. Wrong Medication                     _____F. Wrong Time

Administration:

_____A. Wrong Patient                           _____D. Wrong Medication                ______G. Other (explain on back)

_____B. Wrong Dose                              _____E. Omission

_____C. Wrong Time                              _____F. Commission

 

PART IV: Severity of Event: (Must choose one level)

VARIANCE  LEVEL

RESULT

LEVEL 0

Circumstances or events that have the capacity to cause error

LEVEL 1

An error occurred but the medication did not reach the patient

LEVEL 2

An error occurred that reached the patient with an increased need for monitoring, but did not cause patient harm.

LEVEL 3

An error occurred that resulted in a change in vital sign but no ultimate patient harm

LEVEL 4

An error occurred that resulted in the need for treatment and increase length of stay

LEVEL 5

An error occurred that resulted in permanent patient harm and a need to file a sentinel event report

LEVEL 6

An error occurred that resulted in patient death and a need to file a sentinel event report

 

** Physician findings and orders (for Level 1 through Level 6) __________________________________

______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

 

Signature / Date / Time:  Not Needed Below

 

MD: ________________________________________________________________________________

 

Nurse Manager: _______________________________________________________________________

 

Pharmacy: ____________________________________________________________________________

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Harris County Psychiatric Center University of Texas Health Science Center